对心脏性休克研究和机械循环支持装置的标准化定义:来自休克学术研究联盟 (SHARC) 的科学专家小组
Ron Waksman1, Mohit Pahuja2, Sean van Diepen3
1Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC (R.W.).
Circulation
|October 2, 2023
概括
一个多利益相关方小组制定了心脏性休克临床试验的共识定义. 这些标准化结果定义,包括有效性和安全性,有助于评估机械循环支持装置.
科学领域:
- 心脏病学
- 临床试验方法
- 医疗器械评估
背景情况:
- 心脏性休克 (CS) 患者的试验需要标准化的定义来进行一致的评估.
- 机械循环支持 (MCS) 装置在临床研究中需要明确的结果指标.
研究的目的:
- 建立基于共识的实用定义,用于评估心脏性休克患者的临床试验.
- 标准化与机械循环支持器件相关的试验结果,包括疗效和安全性.
主要方法:
- 召集了包括监管机构,行业和付款人代表在内的多方专家小组.
- 进行文献审查和代专家小组会议 (2020-2022年) 改进定义.
- 负责人负责起草和提出共识建设的定义.
主要成果:
- 为心脏性休克研究中的关键概念和主题制定共识定义.
- 针对标准化疗效和安全性结果的建议.
- 解决基于证据的实践和未来试验的统计分析方面的挑战.
结论:
- 标准化定义对于对心脏性休克临床试验进行可靠的评估至关重要.
- 开发的定义将提高机械循环支持装置的研究质量和可比性.
- 建议支持在重症监护心脏病研究中推进基于证据的实践.
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